Novobismol 120 mg 56 coated tablets

• peptic ulcer disease of the stomach and duodenum in the acute phase, including that associated with Helicobacter pylori;

• chronic gastritis and gastroduodenitis in the acute phase, including that associated with Helicobacter pylori;

• functional dyspepsia not related to organic gastrointestinal diseases;

• irritable bowel syndrome predominantly presenting with diarrhea symptoms.

For adults and children over 12 years old, the medication is prescribed at a dose of 1 tablet 3 times a day 30 minutes before meals and 1 tablet at night, or 2 tablets 2 times a day 30 minutes before meals.
For children aged 8 to 12 years, the medication is prescribed at a dose of 1 tablet 2 times a day 30 minutes before meals.
For children aged 4 to 8 years, the dose is 8 mg/kg/day; the daily dose is divided into 2 administrations. It should be taken 30 minutes before meals.
The tablets should be taken with a small amount of water. The duration of the treatment course is 4-8 weeks. During the following 8 weeks, it is not recommended to use medications containing bismuth. For the eradication of Helicobacter pylori, the use of bismuth subcitrate in combination with other antibacterial agents with anti-Helicobacter activity is advisable.
Dosage regimen, route of administration, and duration of treatment:
The medication should not be used for more than 8 weeks. It is not recommended to exceed the established daily doses for adults and children during treatment with Novobismol®.
During treatment, other medications containing bismuth should not be used.
At the end of the treatment course with the medication at the recommended doses, the concentration of the active ingredient in the blood plasma does not exceed 3-5.8 µg/L, and intoxication is observed only at concentrations above 100 µg/L.
The use of Novobismol® may cause darkening of the stool due to the formation of bismuth sulfide. Occasionally, slight darkening of the tongue may be noted.

Composition per tablet:
bismuth potassium dicitrate 304.6 mg, calculated as bismuth oxide Bi2O3 - 120 mg.
Excipients: corn starch - 70.6 mg, povidone K30 - 17.7 mg, potassium polyacrylate - 23.6 mg, polyethylene glycol 6000 - 6 mg, magnesium stearate - 2 mg.

Round biconvex tablets, coated with a film, cream-white in color, odorless or with a slight smell of ammonia.

• severe renal impairment;

• pregnancy;

• lactation period;

• children under 4 years of age;

• individual intolerance to the drug.

The use of Novobismol® is contraindicated during pregnancy. Breastfeeding should be discontinued during treatment.
Impact of the medicinal product on the ability to drive vehicles and operate machinery
Does not affect the ability to drive a car or operate other machinery.

Gastrointestinal system: possible occurrence of nausea, vomiting, more frequent stools, constipation. These phenomena are not dangerous to health and are temporary in nature.
Allergic reactions: skin rash, itching. With prolonged use in high doses - encephalopathy associated with bismuth accumulation in the CNS.
If any of the side effects listed in the instructions worsen or if any other side effects not listed in the instructions occur, inform your doctor.

Overdose of the drug, caused by prolonged use at doses exceeding the recommended levels, may lead to impaired kidney function. These symptoms are fully reversible upon discontinuation of Novobismol®.

Treatment: upon the appearance of signs of poisoning with the drug, gastric lavage should be performed, activated charcoal and saline laxatives should be administered. Further symptomatic treatment is conducted. In cases of impaired kidney function accompanied by elevated bismuth levels in the plasma, chelating agents such as dimercaptosuccinic acid and dimercaptopropanesulfonic acid may be administered. In cases of severe kidney dysfunction, hemodialysis is indicated.

It is not recommended to take other medications (in particular, antacids) orally, as well as to consume food and liquids, including antacids, milk, fruits, and fruit juices, within half an hour before and after taking Novobismol®. This is due to the fact that they may affect the effectiveness of Novobismol® when taken simultaneously.

Anti-ulcer agent with bactericidal activity against Helicobacter pylori. It also has anti-inflammatory and astringent effects. In the acidic environment of the stomach, insoluble bismuth oxychloride and citrate precipitate, forming chelate compounds with the protein substrate in the form of a protective film on the surface of ulcers and erosions. By increasing the synthesis of prostaglandin E, the formation of mucus, and the secretion of bicarbonate, it stimulates the activity of cytoprotective mechanisms, enhancing the resistance of the gastrointestinal mucosa to the effects of pepsin, hydrochloric acid, enzymes, and bile salts. It leads to the accumulation of epidermal growth factor in the area of the defect. It reduces the activity of pepsin and pepsinogen.

Practically not absorbed from the gastrointestinal tract. Excreted primarily with feces. A small amount of bismuth that enters the plasma is eliminated from the body by the kidneys.

Novobismol is a medication in the form of film-coated tablets. Each tablet contains 120 mg of the active ingredient, bismuth oxide, which is an anti-ulcer agent with bactericidal activity against Helicobacter pylori and also has anti-inflammatory and astringent effects.

Due to its composition, Novobismol forms a protective layer on the surface of the mucous membrane, promoting healing and reducing pain sensations. The medication is recommended for the following conditions:
- Peptic ulcer disease of the stomach and duodenum in the acute phase;
- Chronic gastritis and gastroduodenitis in the acute phase;
- Functional dyspepsia not associated with organic gastrointestinal diseases;
- Irritable bowel syndrome predominantly presenting with diarrhea symptoms.

It is not recommended to exceed the established daily doses for adults and children during treatment with Novobismol. During the treatment period, other medications containing bismuth should not be used. Consult a doctor before use.